Guidance
University of Michigan Human Research Protection Program Operations Manual (OM)--The OM is designed to illuminate the University of Michigan's overarching governing rules and to serve as a reference for investigators, IRBs, administrators, and others.
Click the Education link, left, for information about IRBMED workshops on IRB forms and policies.
A-B
- Adverse Event Reporting
- Advertising (see Recruitment Advertising below)
- Belmont Report--Ethical Principles
- Blood Draw Guidelines
C
- Certificate of Confidentiality (NIH website)
- Children in Research
- Assent (pediatric subject's agreement to participate in research)
- HHS Office of Human Research Protections (OHRP) FAQ on child/parent disagreements on partcipation
- National Cancer Institute Guidance (helpful information for all types of research)
- Federal Regulations and Guidance for Children, HHS Office of Human Research Protections (OHRP)
- Federal Regulations for research involving children, HHS Food and Drug Administration (FDA)
- OHRP Frequently Asked Questions
- Research involving greater risk than 'minor increase over minimal' without direct benefit for subjects --OHRP Guidance for 45 CFR 46.407
- Food and Drug Administration 'Pediatric Drug Development' Guidance
- Wards of the State as Research Subjects
- Assent (pediatric subject's agreement to participate in research)
- Clinical Trials Registration
- Complaints from Subject or Others about a Research Study
E
- Eligibility Screening
- Embryonic (human) Stem Cells
- Emergency Use of Test Articles
- Emergency Research with Exception from Informed Consent
- eResearch
- Basic Step-by-Step Manuals:
- Frequently As Questions
- Glossary of eResearch Terms
- Pre-submission Checklist--Things to have, information to gather before starting a submission
- Quick Reference Card
- Tips--Miscellaneous ways to optimize eResearch
- Exempt Research
- Expedited Review
- Expiration Date (see General Guidelines)
F-H
- FDA information about INDs or IDEs see Investigational New Drug Application or Investgational Device Excemption below
- Federal Regulations
- 21 CFR 50 Regulations enforced by the Food and Drug Administration (FDA)-- Protection of Human Subjects
- 21 CFR 56 FDA--Institutional Review Boards
- 45 CFR 46 Regulations enforced by the Department of Health and Human Services Office of Human Research Protections (OHRP)
- OHRP 45 CFR 46 FAQs
- OHRP Federalwide Assurance FAQ
- Fees for IRBMED Review of Sponsored Projects
- Fetuses
- General Guidelines
- University of Michigan Human Research Protection Program Operations Manual (OM)--The OM is designed to illuminate the University of Michigan's overarching governing rules and to serve as a reference for investigators, IRBs, administrators, and others.
- Genetic and DNA Based Research
- HIPAA Guidance
- HIPAA and Research - IRBMED Quick Guide
- Helpful Links to Other Sites
- Privacy Board (forms and information)
- Questions about HIPAA
I
- IDE (see Investigational Device Exemption below)
- IND (see Investigational New Drug Application below)
- Informed Consent Guidance
- Additional Required Elements under HIPAA
- Children (see above, Children in Research, Assent)
- Emergency Research with Exception from Informed Consent
- Frequently Asked Questions (OHRP)
- Non-English Speaking Subjects
- Process
- Simplification Guide to Medical Terms (Glossary)
- Telephone (see Telephonic Consent)
- Template-What's New
- Tips on Preparing Understandable Informed Consent Documents
- Waiver under OHRP, FDA & HIPAA Regulations
- Who can Consent or Provide Permission for Participation in Research
- International Research
- IRBMED Help Guide on International Research
- International Compilation of Human Subject Research Protections (PDF document listing the laws, regulations, and guidelines that govern human subjects research in many countries around the world)
- Miscellaneous International Resources at DHHS Office of Human Research Protections (OHRP)
- Investigational Device Exemption (IDE) Application
- Investigational New Drug (IND) Application
- Decision tree to determine an IND is required
- Bioavailability or Bioequivalence Studies--Decision tree to determine if an IND is required
- Investigator Responsibilities
N-P
- Neonates
- Other Reportable Events and Information (ORIO Reporting)
- Payment to Research Subjects
- Prisoners and Research
- Federal Guidance (Office of Human Research Protections (OHRP))
- OHRP FAQs
- New study enrolling prisoners (OVPR webpage)
- Subject becomes a prisoner / Study not previously approved to recruit prisoners seeks to enroll new subject who is a prisoner
- Privacy Board (forms and information)
- Protocol Deviations, Exceptions, Violations
R
- Radiation Exposure Guide
- Record Retention--How Long to Research Records
- Recruitment Advertising
- Removal of Blood
- Reports to or from Oversight Agencies, Boards, Committees, etc. (e.g. DSMB, FDA)
- Risk--Guidelines For Using Magnitude Of Harm In Categorizing Risk Level
S-T
- Signatures on Applications
- Standard Operating Procedures (IRBMED)
- Telephonic Consent
- Test Articles in Research
- Biologics and Vaccines
- Charging for Investigational Products
- Investigational Drugs
- General Information
- FDA IND Contact List (to determine if an IND is needed for off-label drug use in research or for a new drug, herb, or nutritional supplement)
- Study Design
- Investigational Devices
- Software Guidance (software may require an investigational device exemption from the FDA)
U-Z
- Unanticipated Problems involving research subjects or others
- Vulnerable Populations (links to HHS Office of Human Research Protections)
- Wards of the State as Research Subjects
- What's New on Applications
- What's New on the Consent Template
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of the University of Michigan
